Clinical trial · Interventional

High-dose ICE With Amifostine

High Dose Ifosfamide, Carboplatin and Etoposide With Amifostine Chemoprotection

NCT00003657CI-TRIAL-00025557completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The purpose of the study is to evaluate the combination of amifostine and high dose chemotherapy with blood stem cell support. Amifostine is a druf developed to protect normal tissues against the toxicities of chemotherapy and radiotherapy and has reduced the side effects of chemotherapy given at conventional doses.

Conditions

Conditions (11)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Bladder Cancer	Malignant Bladder Neoplasm	CURATED_EXACT	0.92
Brain and Central Nervous System Tumors	—	UNRESOLVED	—
Carcinoma of Unknown Primary	Carcinoma of Unknown Primary	ONTOLOGY_EXACT	0.98
Extragonadal Germ Cell Tumor	Extragonadal Germ Cell Tumor	ONTOLOGY_EXACT	0.98
Head and Neck Cancer	Malignant Head and Neck Neoplasm	ALIAS	0.90
Kidney Cancer	Malignant Kidney Neoplasm	CURATED_EXACT	0.92
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92
Ovarian Cancer	Malignant Ovarian Neoplasm	CURATED_EXACT	0.92
Sarcoma	Sarcoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (6)

Intervention	Type	Mapped drug	Match
Amifostine	Drug	—	UNRESOLVED
Carboplatin	Drug	Carboplatin	ALIAS
Etoposide	Drug	Etoposide	ALIAS
filgrastim	Biological	Filgrastim	ALIAS
Ifosfamide	Drug	Ifosfamide	ALIAS
peripheral blood stem cell transplantation	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
High Dose ICF with Amifostine
description
* Patients undergo peripheral blood stem cell transplantation (PBSC) harvest on day -8, * ifosfamide IV, carboplatin IV etoposide IV (ICE) by 96 hour continuous infusion on days -7 to -4. * Patients receive amifostine IV twice a day on days -7 to -3. * PBSCs are reinfused on day 0. * Filgrastim (G-CSF) is administered subcutaneously beginning on day 0 at least 2 hours after infusion of the stem cells and continuing until blood cell counts recover. * Patients are followed monthly for the first 2 months and then for survival.
interventionNames
1. Biological: filgrastim
2. Drug: Amifostine
3. Drug: Carboplatin
4. Drug: Etoposide
5. Drug: Ifosfamide
6. Procedure: peripheral blood stem cell transplantation

Primary outcomes (1)

measure
Percentage of Participants with Grade 2 or higher renal toxicities
timeFrame
2 Months

Secondary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 55 Years

Show eligibility criteria text

Eligibility Criteria:

* Histologically documented malignancy
* Metastatic or locally unresectable malignancy
* Patient may be responding to therapy

  * Responding Stage IIIC/IV or recurrent/refractory ovarian carcinoma (ineligible for other bone marrow or stem cell transplant protocols)
  * Relapsed germ cell carcinomas
  * Relapsed lymphomas (ineligible for other BMT or SCT protocols
  * SCLC in PR or CR
  * Sarcomas in or near complete remission after induction chemotherapy
  * Stage IIIB NSCLC responding to chemotherapy
  * Responsive bladder, head and neck carcinoma, or carcinoma of unknown primary
  * Other tumors without curative or first line therapy (not eligible for phase II or III studies)
* Aged 18 to 55 Physiologic years

  \-- Performance status: PS 0-1
* Prior Treatment

  * \> 1 week since surgery or RT
  * \> 3 weeks since prior CT
* Informed Consent
* Required initial laboratory data:

  * White Cell Count Life ≥ 3000/ul
  * Platelet Count ≥ 100,000/ul
  * Creatinine ≤ 1.5 x normal
  * Bilirubin ≤ 1.5 x normal
  * No current metastases

    * BM Asp \& Bx
    * Brain CAT
  * Creatinine Clearance ≥ 60 cc/min
  * SGOT \< 2.5 x normal
* No other serious medical or psychiatric illness which would prevent informed consent or general anesthesia

  * Uncontrolled or severe cardiovascular disease including recent (\< 6 months) myocardial infarction, or congestive heart failure
  * Active uncontrolled bacterial, viral, or fungal infection; or an active duodenal ulcer; until these conditions are corrected or controlled
  * Pregnancy
  * Unable to stop taking antihypertensive medication 24 hours prior to administration of Ethyol

References

Publications (1)

RESULTElias AD, Richardson P, Tretyakov O, et al.: Amifostine with high dose infosfamide, carboplatin, and etoposide (ICE) with hematopoietic STEM cell support. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A197, 2000.

Registry

Dates and enrollment